Method and apparatus for controlled contraction of soft tissue

ABSTRACT

An apparatus and method are provided for control contraction of tissue that includes collagen fibers. The apparatus includes a handpiece, and an electrode with an electrode proximal end associated with the handpiece. A distal end of the electrode has a geometry that delivers a controlled amount of energy to the tissue for a desired contraction of the collagen fibers. This is achieved while dissociation and breakdown of the collagen fibers is minimized. The handpiece, with electrode, is adapted to be introduced through an operating cannula in percutaneous applications. Additionally, an operating cannula may be included in the apparatus and be attached to the handpiece. The apparatus and method provides for a desired level of contraction of collagen soft tissue without dissociation or breakdown of collagen fibers.

This application is a continuation, of Application Ser. No. 08/238,862,filed May 6, 94, U.S. Pat. No. 5,458,596.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to the contraction of soft tissue, andmore particularly, to the compaction of soft collagen tissue withminimal dissociation of collagen tissue.

2. Description of the Related Art

Instability of peripheral joints has long been recognized as asignificant cause of disability and functional limitation in patientswho are active in their daily activities, work or sports. Diarthrodialjoints of musculoskeletal system have varying degrees of intrinsicstability based on joint geometry and ligament and soft tissueinvestment. Diarthrodial joints are comprised of the articulation of theends of bones and their covering of hyaline cartilage surrounded by asoft tissue joint capsule that maintains the constant contact of thecartilage surfaces. This joint capsule also maintains within the jointthe synovial fluid that provides nutrition and lubrication of the jointsurfaces. Ligaments are soft tissue condensations in or around the jointcapsule that reinforce and hold the joint together while alsocontrolling and restricting various movements of the joints. Theligaments, joint capsule, and connective tissue are largely comprised ofcollagen.

When a joint becomes unstable, its soft tissue or bony structures allowfor excessive motion of the joint surfaces relative to each other and indirections not normally permitted by the ligaments or capsule. When onesurface of a joint slides out of position relative to the other surface,but some contact remains, subluxation occurs. When one surface of thejoint completely disengages and loses contact with the opposing surface,a dislocation occurs. Typically, the more motion a joint normallydemonstrates, the more inherently loose the soft tissue investment issurrounding the joint. This makes some joints more prone to instabilitythan others. The shoulder, (glenohumeral) joint, for example, has thegreatest range of motion of all peripheral joints. It has long beenrecognized as having the highest subluxation and dislocation ratebecause of its inherent laxity relative to more constrained "ball andsocket" joints such as the hip.

Instability of the shoulder can occur congenitally, developmentally, ortraumatically and often becomes recurrent, necessitating surgicalrepair. In fact subluxations and dislocations are a common occurrenceand cause for a large number of orthopedic procedures each year.Symptoms include pain, instability, weakness, and limitation offunction. If the instability is severe and recurrent, functionalincapacity and arthritis may result. Surgical attempts are directedtoward tightening the soft tissue restraints that have becomepathologically loose. These procedures are typically performed throughopen surgical approaches that often require hospitalization andprolonged rehabilitation programs.

More recently, endoscopic (arthroscopic) techniques for achieving thesesame goals have been explored with variable success. Endoscopictechniques have the advantage of being performed through smallerincisions and therefore are usually less painful, performed on anoutpatient basis, are associated with less blood loss and lower risk ofinfection and have a more cosmetically acceptable scar. Recovery isoften faster postoperatively than using open techniques. However, it isoften more technically demanding to advance and tighten capsule orligamentous tissue arthroscopically because of the difficult access topathologically loose tissue and because it is very hard to determine howmuch tightening or advancement of the lax tissue is clinicallynecessary. In addition, fixation of advanced or tightened soft tissue ismore difficult arthroscopically than through open surgical methods.

Collagen connective tissue is ubiquitous in the human body anddemonstrates several unique characteristics not found in other tissues.It provides the cohesiveness of the musculoskeletal system, thestructural integrity of the viscera as well as the elasticity ofintegument. These are basically five types of collagen molecules withType I being most common in bone, tendon, skin and other connectivetissues, and Type III is common in muscular and elastic tissues.

Intermolecular cross links provide collagen connective tissue withunique physical properties of high tensile strength and substantialelasticity. A previously recognized property of collagen is hydrothermalshrinkage of collagen fibers when elevated in temperature. This uniquemolecular response to temperature elevation is the result of rupture ofthe collagen stabilizing cross links and immediate contraction of thecollagen fibers to about one-third of their original lineal distention.Additionally, the caliber of the individual fibers increases greatly,over four fold, without changing the structural integrity of theconnection tissue.

There has been discussion in the existing literature regardingalteration of collagen connective tissue in different parts of the body.One known technique for effective use of this knowledge of theproperties of collagen is through the use of infrared laser energy toeffect tissue heating. The use of infrared laser energy as a cornealcollagen shrinking tool of the eye has been described and relates tolaser keratoplasty, as set forth in U.S. Pat. No. 4,976,709. Theimportance controlling the localization, timing and intensity of laserenergy delivery is recognized as paramount in providing the desired softtissue shrinkage effects without creating excessive damage to thesurrounding non-target tissues.

Radiofrequency (RF) electrical current has been used to reshape thecornea. Such shaping has been reported by Doss in U.S. Pat. Nos.4,326,529; and 4.381,007. However, Doss was not concerned withdissociating collagen tissue in his reshaping of the cornea.

Shrinkage of collagen tissue is important in many applications. One suchapplication is the shoulder capsule. The capsule of the shoulderconsists of a synovial lining and three well defined layers of collagen.The fibers of the inner and outer layers extend in a coronal access fromthe glenoid to the humerus. The middle layer of the collagen extends ina sagittal direction, crossing the fibers of the other two layers. Therelative thickness and degree of intermingling of collagen fibers of thethree layers vary with different portions of the capsule. Theligamentous components of the capsule are represented by abruptthickenings of the inner layer with a significant increase in wellorganized coarse collagen bundles in the coronal plane.

The capsule functions as a hammock-like sling to support the humeralhead. In pathologic states of recurrent traumatic or developmentalinstability this capsule or pouch becomes attenuated and the capsulecapacity increases secondary to capsule redundance. In cases ofcongenital or developmental multi-directional laxity, an altered ratioof type I to type III collagen fibers may be noted. In these shouldercapsules a higher ratio of more elastic type III collagen has beendescribed.

There is a need for a method and apparatus to effect controlled linealcontraction or shrinkage of collagen fibers to provide a multitude ofnon-destructive and beneficial structural changes and corrections withinthe body. More particularly with regard to the shoulder capsule, currentsurgical techniques involve cutting or advancing the shoulder capsule toeliminate capsular redundance or to otherwise tighten the ligamouscomplex. Accordingly, there is a need to control shrinkage of thecapsule by utilizing the knowledge of the properties of collagen inresponse to a specific level of thermal application.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a method andapparatus to control the duration and application of thermal energy to atissue site made that includes collagen soft tissue; a desired level ofcontraction of collagen fibers is obtained while dissociation andbreakdown of the collagen fibers is minimized.

Another object of the present invention is to use RF heating in a fluidenvironment to control thermal spread to a tissue that includes collagensoft tissue, and a desired contraction of collagen fibers is obtainedwhile minimizing dissociation and breakdown of the collagen fibers.

Yet another object of the present invention is to provide a devicedirected to collagen connective tissue shrinkage by the use of RFheating to a temperature profile of 43 to 90 degrees centigrade.

Another object of the present invention is to provide a device directedto collagen connective tissue shrinkage by the use of RF heating to atemperature profile of 43 to 75 degrees centigrade.

Still a further object of the present invention is to provide a devicedirected to collagen connective tissue shrinkage by the use of the RFheating to a temperature profile of 45 to 60 degrees centigrade.

Another object of the present invention is to provide an apparatus whichdelivers RF energy through an endoscopically guided handpiece in a fluidenvironment to obtain maximum contraction of collagen soft tissue whileminimizing dissociation and breakdown of the collagen tissue.

Yet another object of the present invention is to provide an apparatusthat provides for the maximum amount of collagen contraction withoutdissociation of the collagen structure.

Another object of the present invention is to provide an apparatus todeliver a controlled amount of RF energy to the collagen soft tissue ofa joint in order to contract and restrict the soft tissue elasticity andimprove joint stability.

A further object of the present invention to provide an apparatus andmethod that reduces redundancy of the shoulder capsule and improvesstability to the joint.

These and other objects of the invention are obtained with an apparatusfor control contraction of tissue that includes collagen fibers. Theapparatus include a handpiece, and an electrode with an electrodeproximal end that is associated with the handpiece. A distal end of theelectrode has a geometry that delivers a controlled amount of energy tothe tissue in order to achieve a desired contraction of the collagenfibers. This is achieved while dissociation and breakdown of thecollagen fibers is minimized.

The handpiece, with electrode, is adapted to be introduced through anoperating cannula in percutaneous applications. Additionally, it may bedesirable to include as part of the apparatus an operating cannula. Inthis instance, the operating cannula has a proximal end that attaches tothe handpiece, and a distal end that is adapted to be introduced into abody structure. The electrode is positioned within the operatingcannula, and extendable beyond the distal end of the cannula whenthermal energy is delivered to the tissue.

It is recognized that the delivery of the thermal energy to the tissueshould be delivered in such a way that none of the tissue is ablated.Additionally, the delivery is achieved without dissociating or breakingdown the collagen structure. This can be accomplished in different ways,but it has been discovered that an electrode with radiused edges at itsdistal end is suitable to obtain this result. The present invention isapplicable to a number of different anatomical sites. Depending on theanatomy, it may be necessary to deflect the distal end of the electrodeto reach the desired site. Additionally, one side of the electrode mayinclude an insulating layer so that thermal energy is only delivered tothe intended tissue, and not a tissue in an adjacent relationship to thearea of treatment.

In certain instances it is desirable to be able to vary the length ofthe electrode conductive surface which delivers the thermal energy tothe tissue. For this purpose, an adjustable insulator, that is capableof movement along the longitudinal axis of the electrode, provides a wayof adjusting the length of electrode conductive surface.

Memory metals can be used for the electrode construction. An advantageof memory metals is that with the application of heat to the metal, itcan be caused to be deflected. This is particularly useful fordeflecting the distal end of the electrode.

The electrode can include a central lumen that receives an electrolyticsolution from an electrolytic source. A plurality of apertures areformed in the distal end of the electrode and deliver the flowingelectrolytic fluid to the tissue. Instead of an electrolytic solution,an electrolytic gel can also be introduced through the electrode.

In one embodiment of the invention, the electrode is partiallysurrounded by an insulating housing in order to position the electrodein an adjacent but spaced relationship to the tissue. A portion of theinsulating housing rides on the tissue, and creates the equivalent of apartial dam for electrolytic solution introduced through the electrodeand towards the tissue. A cuff is disposed about the insulating housing.The cuff and insulating housing together create a return electrolyticsolution channel for the removal of solution flowing out of the dam andaway from the tissue site.

The handpiece of the invention can be connected, with a cable, to an RFenergy source. A closed loop feedback system can be included and coupledto a temperature sensor on the electrode and the RF energy source.Temperature at the electrode can be monitored, and the power of the RFenergy source adjusted to control the amount of energy that is deliveredto the tissue.

The present invention has wide spread application to many differentanatomical locations. It can be utilized for controlled contraction ofcollagen soft tissue of a joint capsule, particularly the gleno-humoraljoint capsule of the shoulder, to treat herniated discs, the meniscus ofthe knee, for dermatology, to name just a few.

In one embodiment of the invention, RF heating in a fluid or salineenvironment is used to control thermal spread to soft collagen tissue.The RF energy can be delivered through an endoscopically guidedhandpiece under arthroscopic visualization by the surgeon. In thetemperature range of 43 to 90 degrees C., maximum collagen contractionis achieved. Additional temperature ranges are 43 to 75 degrees C., and45 to 60 degrees C. Lower temperatures do not provide maximum thermalinduced contracture of the collagen fibrils. Greater temperatures createexcessive destruction and disintegration of the collagen fibrillarpattern. Thus, the present invention is a method and apparatus whichaccurately controls the application of heat within a desired thermalrange. This heat is delivered the collagen soft tissue, therebycontracting and restricting the soft tissue elasticity and improvingstability.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective plan view of an apparatus for controlcontraction of tissue that includes collagen fibers, including ahandpiece and an electrode, according to the invention.

FIG. 2 is a perspective plan view of a distal end of the electrode withall edges radiused according to the invention.

FIG. 3 is a side view of the distal end of the electrode of FIG. 2.

FIG. 4 is a sectional view of the deflected electrode with a resistiveheating element positioned in an interior lumen of the electrodeaccording to the invention.

FIG. 5 is a perspective plan view of the apparatus for controlcontraction of tissue with collagen fibers with a handpiece, electrodeand an operating cannula according to the present invention.

FIG. 6 is a close up perspective plan view of the distal end of theelectrode of the apparatus of FIG. 5 according to the invention.

FIG. 7 is a perspective plan view of an electrode with a steering wirepositioned on the exterior of the electrode according to the invention.

FIG. 8 is a sectional view of an electrode with a lumen and a plug thatis attached to the electrode distal end according to the invention.

FIG. 9 is a cross sectional view of an electrode with fluid flowingthrough an interior lumen of the electrode according to the invention.

FIG. 10 is a cross sectional view of an RF electrode structure with aninsulating housing surrounding a portion of an electrode, and a cuffsurrounding the insulating housing according to the invention.

FIG. 11 is a block diagram of a fluid control system useful with theelectrode structure of FIG. 10 according to the invention.

FIG. 12 is a perspective plan view of a handpiece, an electrode and asleeve that slides across the surface of the electrode to vary theamount of electrode conductive surface according to the invention.

FIG. 13 is a sectional view of an electrode with an oval cross sectionand the heating zone in the tissue according to the invention.

FIG. 14 is a sectional view of a handle, electrode, operating cannulaand a viewing scope, with the viewing scope and electrode positioned inthe operating cannula according to the invention.

FIG. 15 is a cross sectional view of the device of FIG. 14, taken alongthe lines 15--15 according to the invention.

FIG. 16 is a perspective plan view of an electrode distal end withtemperature sensors positioned in the distal end according to theinvention.

FIG. 17 is a block diagram of a closed loop feedback system according tothe invention.

FIG. 18 is a perspective plan view of a roller element mounted at anelectrode distal end according to the invention.

FIG. 19 is a drawing of the right glenohueral capsuloligamentouscomplex.

FIG. 20 is a drawing of a loose joint capsule.

FIG. 21 is a schematic drawing of the apparatus of the invention with anelectrode supplying thermal energy to a joint structure.

FIG. 22 is a sectional view of a disc positioned between two vertebrae.

FIG. 23 is a schematic drawing of the apparatus of the invention with anelectrode supplying thermal energy to a herniated disc.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now generally to FIG. 1, an apparatus for control contractionof tissue that includes collagen fibers is generally denoted as 10.Apparatus 10 includes a handpiece 12 that is preferably made of aninsulating material. Types of such insulating materials are well knownin those skilled in the art; An electrode 14 is associated with handle12 at a proximal end 16 of electrode 14, and may even be attachedthereto. A distal end 18 of electrode 14 has a geometry that delivers acontrolled amount of energy to the tissue in order to achieve a desiredlevel of contraction of the collagen fibers. Contraction is achievedwhile dissociation and breakdown of the collagen fibers is minimized.

Electrode 14 can have be a flat elongated structure that is easilypainted across a tissue without "hanging up" on any section of thetissue. In one geometry of electrode 14, all edges 20 of distal end 18are radiused, as illustrated in FIGS. 2 and 3. Distal end 18 can have avariety of geometric configurations. One such geometry is a disc shapedgeometry without square edges. Electrode 14 can be made of a number ofdifferent materials including but not limited to stainless steel,platinum, other noble metals and the like. Electrode 14 can be made of amemory metal, such as nickel titanium, commercially available fromRaychem Corporation, Menlo Park, Calif. In FIG. 4, a resistive heatingelement 22 can be positioned in an interior lumen of electrode 14.Resistive heating element can be made of a suitable metal that transfersheat to electrode 14, causing electrode distal end 18 to becomedeflected when the temperature of electrode 14 reaches a level that thememory metal is caused to deflect, as is well known in the art. Not allof electrode 14 need be made of the memory metal. It is possible thatonly electrode distal end 18 be made of the memory metal in order toeffect the desired deflection. There are other methods of deflectingelectrode 18, as will be more fully discussed and described in a latersection of this specification.

Apparatus 10, comprising handpiece 12 and electrode 14, is adapted to beintroduced through an operating cannula for percutaneous applications.It will be appreciated that apparatus 10 may be used in non-percutaneousapplications and that an operating cannula is not necessary in the broadapplication of the invention.

As illustrated in FIGS. 5 and 6, apparatus 10 can also include, as anintegral member, an operating cannula 24 which can be in the form of ahyperdermic trocar with dimensions of about 3 to 6 mm outside diameter,with tubular geometries such as those of standard commercially availableoperating cannulas. Operating cannula 24 can be made of a variety ofbiocompatible materials including but not limited to stainless steel,and the like.

Operating cannula 24 has a proximal end that attaches to handpiece 12and it can have a sharp or piercing distal end 26 that pierces a bodystructure in order to introduce electrode 14 to a desired site.Electrode 14 is positioned within an interior lumen of operating cannula24 and is extendable beyond distal end 26 in order to reach the desiredtissue site. Electrode 14 can be advanced and retracted in and out ofoperating cannula 24 by activating a deployment button 28 which islocated on the exterior of handle 12. Deployment button 28 is preferablyactivated by the operator merely by sliding it, which causes electrode14 to advance in a direction away from distal end 26 of operatingcannula 24. Deployment button 28 can be pulled back, causing aretraction of electrode 14 towards distal end 26. In many instances,electrode 14 will be retracted to be positioned entirely withinoperating cannula 14. Electrode 14 can also deployed with fluidhydraulics, pneumatics, servo motors, linear actuators, and the like.

An electrical and/or fluid flow cable 28 attaches to handle 12 andprovides the necessary connection of apparatus 10 to a suitable energysource and/or a source of fluid, which may be an electrolytic solutionor an electrolytic gel. An electrolytic solution, for purposes of thisinvention, is one that increases the transfer of thermal energy fromelectrode 14 to a tissue. Suitable electrolytic solutions include butare not limited to saline solution and the like.

A variety of energy sources can be used with the present invention totransfer thermal energy to the tissue that includes collagen fibers.Such energy sources include but are not limited to RF, microwave,ultrasonic, coherent light and thermal transfer.

When an RF energy source is used, the physician can activate the energysource by the use of a foot switch 30 that is associated with handle 12and electrode 14. Significantly, a controlled amount of RF energy isdelivered so that there is an effective transfer of thermal energy tothe tissue site so that the thermal energy spreads widely through thetissue but does not cause a dissociation or breakdown of the collagenfibers.

For many applications, it is necessary to have electrode distal end 18to become deflected (FIG. 6). This can be achieved with the use ofmemory metals, or it can be accomplished mechanically. A steering wire,or other mechanical structure, is attached to either the exterior orinterior of electrode 14. A deflection button 32, located on handle 12,is activated by the physician, causing steering wire 34 (FIG. 7) totighten, and impart an retraction of electrode 14, resulting in adeflection of electrode distal end 18. It will be appreciated that othermechanical mechanisms can be used in place of steering wire 34. Thedeflection may be desirable for tissue sites that have difficult access,and it is necessary to move about a non-linear tissue. By deflectingelectrode distal end 18, the opportunity to provide more even thermalenergy to a tissue site is achieved, and the possibility of ablating ordissociation of collagen material is greatly reduced.

As shown in FIG. 7, steering wire 34 attaches to a flat formed on theexterior of electrode 14. Wire EDM technology can be used to form theflat on electrode 14. A "T" bar configuration is illustrated in FIG. 7.Chemical etching may be used to create the "T" bar. Steering wire 34need not be an actual wire. It can also be a high tensile strength cordsuch as Kevlar. Steering wire 34 can be made of stainless steel flatwire, sheet material, and the like.

Electrode 14 can be tubular in nature with a central lumen. Electrodedistal end 18 can include a conductive plug that is sealed to electrodedistal end 18 by welding, e-beam, laser, and the like.

In FIG. 9, Electrode 14 can include an electrical insulation layer 38formed on a back side of electrode 14 which is intended to minimizedamage to tissue areas that are not treated. For example, when electrode14 is introduced into a tight area, and only one surface of the tightarea is to be treated, then it desirable to avoid delivering thermalenergy to other tissue site areas. The inclusion of insulation layer 38accomplishes this result. Suitable insulation materials include but arenot limited to polyimide, epoxy varnish, PVC and the like. Electrode 14includes a conductive surface 40 which does not include insulation layer38.

A plurality of apertures 42 are formed in electrode 14 to introduce aflowing fluid 44 through an interior lumen of electrode 14 and to thetissue site. The flowing fluid can be an electrolytic solution or gel,including but not limited to saline. The electrolyte furnishes anefficient electrical path and contact between electrode 14 and thetissue to be heated.

Referring now to FIG. 10, electrode 14 includes a central lumen forreceiving an electrolytic solution 44 from an electrolytic source.Electrolytic solution 44 flows from electrode 14 through a plurality ofapertures 42 formed in conductive surface 40. An insulating housing 46surrounds electrode 14, leaving only conductive surface 40 exposed.Insulating housing 46 can be formed of a variety of non-electricallyconducting materials including but not limited to thermoplastics,thermosetting plastic resins, ceramics, and the like. Insulating housing46 rides along the surface of the tissue to be treated and positionsconductive surface 40 in an adjacent but spaced relationship with thetissue. In this manner, there isn't direct contact of conductive surface40 with the tissue, and the chance of dissociation or break down of thecollagen fibers is reduced. Insulating housing 46 creates a partial dam48 of electrolytic solution adjacent to the tissue. Electrical energy istransferred from electrode 14 to electrolytic solution 44, and fromelectrolytic solution 44 in dam 48 to the tissue. A cuff 50 surroundsinsulating housing 46. Cuff 50 may be made of a variety of materialsincluding but not limited to thermoplastic, thermosetting plasticresins, ceramics and the like. The respective dimensions of insulatinghousing 46 and cuff can vary according to the specific application. Forexample, in percutaneous applications, the dimensions will be smallerthan for those used in topical applications such as dermatology.

Cuff 50 and insulating housing 46 are closely positioned to each other,but they are spaced in a manner to create a return electrolytic solutionchannel 52. The used electrolyte solution may either be released withina confined body area, such as the joint, or not be returned to thetissue, but instead is removed.

Use of a cooled solution to deliver the thermal energy to the tissue,instead of direct contact with conductive surface 40, provides a moreeven thermal gradient in the tissue. Avoidance of surface overheatingcan be accomplished. There is a more uniform level of thermal energyapplied to the tissue. Electrolytic solution 44 may be cooled in therange of about 30 to 55 degrees C.

Referring now to FIG. 11, electrolytic solution 44 is in a holdingcontainer 54 and transferred through a fluid conduit 56 to a temperaturecontroller 58 which can cool and heat electrolytic solution 44 to adesired temperature. A pump 60 is associated with fluid conduit 56 totransfer fluid throughout the system and delivers electrolytic solution44 through handpiece 12 to electrode 14. Returning electrolytic fluid 44passes through return electrolytic solution channel 52, and is deliveredto a waste container 62. The flow rate of electrolytic solution can bein the range of less than about 1 cc/min. to greater than 5 cc/second.

The area of electrode 14 that serves as conductive surface 44 can beadjusted by the inclusion of an insulating sleeve 64 (FIG. 12) that ispositioned around electrode 14. Sleeve 64 is advanced and retractedalong the surface of electrode 14 in order to provide increase ordecrease the surface area of conductive surface 44 that is directed tothe tissue. Sleeve 64 can be made of a variety of materials includingbut not limited to nylon, polyimides, other thermoplastics and the like.The amount of available conductive surface 44 available to deliverthermal energy can be achieved with devices other than sleeve 64,including but not limited to printed circuitry with multiple circuitsthat can be individually activated, and the like.

Electrode 14 can have a variety of different geometric configurations.In one embodiment, electrode 14 has an oval cross section (FIG. 13). Theoval cross section provides a greater conductive surface 44 area that isin contact with the tissue. A larger zone of heating to the tissue isprovided. The thermal gradient within the tissue is more even and thepossible dissociation or breakdown of the collagen fibers is reduced.

As illustrated in FIG. 14, operating cannula 24 includes a viewing scope66 which may be positioned above electrode 14 (FIG. 15). Viewing scope66 provides a field of view 68, permitting the surgeon to view whiledelivering energy to the tissue site and contracting the tissue. Viewingscope 66 can include a bundle light transmitting fibers and opticalviewing elements. Alternatively, the surgeon can view the procedureunder arthroscopic visualization.

Referring now to FIG. 16, one or more temperature sensors 70 can bepositioned in electrode 14, particularly at electrode distal end 18.Temperature sensor 70 can be a thermocouple, a thermistor or phosphorcoated optical fibers. Temperature sensor 70 can be utilized todetermine the temperature of electrode 14, particularly at conductivesurface 40, or temperature sensor 70 may be employed to determine thetemperature of the tissue site.

Additionally, the apparatus of the present invention can be an RF energydelivery device to effect contraction of collagen soft tissue whileminimizing dissociation or breakdown of the collagen fibers. As shown inFIG. 17 the apparatus for control contraction of collagen soft tissuecan include handpiece 12, electrode 14, operating cannula 24, a cable 28and an RF power source 72. Suitable RF power sources are commerciallyavailable and well known to those skilled in the art. In one embodimentof the invention RF power source 72 has a single channel, deliveringapproximately 30 watts of RF energy and possess continued flowcapability. A closed loop feedback system, coupling temperature sensor70 to RF energy source 72 can be included. The temperature of thetissue, or of electrode 14 is monitored, and the power of RF generator72 adjusted accordingly. The physician can, if desired, override theclosed loop system. A microprocessor 74 can be included and incorporatedinto the closed loop system switch power on and off, as well as modulatethe power. A suitable microprocessor is commercially available and wellknown to those skilled in the art of closed loop feedback systems. Theclosed loop system utilizes microprocessor 74 to serve as a controller,watch the temperature, adjust the RF power, look at the result, refedthe result, and then modulates the power.

Optionally positioned on electrode distal end 18 is a conductive rollerelement 76 (FIG. 18). Conductive roller element is rotatably mounted onelectrode distal end 18 and can include a plurality of projections 78.Roller element 76 is moved across the tissue site, along withprojections 78, to deliver the thermal energy.

The present invention provides a method of contracting collagen softtissue. The collagen soft tissue is contracted to a desired shrinkagelevel without dissociation and breakdown of the collagen structure. Itcan be used in the shoulder, spine, cosmetic applications, and the like.It will be appreciated to those skilled in the art that the presentinvention has a variety of different applications, not merely thosespecifically mentioned in this specification. Some specific applicationsinclude joint capsules, specifically the gleno-humoral joint capsule ofthe shoulder, herniated discs, the meniscus of the knee, in the bowel,for hiatal hernias, abdominal hernias, bladder suspensions, tissuewelding, DRS, and the like.

RF energy, thermal energy, is delivered to collagen soft tissue. Thethermal energy penetrates more than 1 mm through the collagen softtissue. The penetration can be as much as about 3 mm. Electrode 14 ispainted across the collagen soft tissue sequentially until the maximumshrinkage occurs. In one embodiment, the collagen soft tissue iscontracted in an amount of about two-thirds of its resting weight. Atemperature range of about 43 to 90 degrees C. is preferred. Morepreferred, the temperature range is about 43 to 75 degrees C. Still morepreferred is a temperature range of 45 to 60 degrees C.

In one specific embodiment of the invention, joint capsules are treatedto eliminate capsular redundance. More specifically, the invention isutilized to contract soft collagen tissue in the gleno-humoral jointcapsule of the shoulder. The basic anatomy of the gleno-humoral jointcapsule of the shoulder is illustrated in FIG. 19.

The apparatus of the present invention provides RF heating in a fluid orsaline environment to control thermal spread. RF heating is applied tocollagen connective tissue shrinkage in temperature ranges of about 43to 90 degrees C., 43 to 75 degrees C. and 45 to 60 degrees C. The RFenergy is delivered through endoscopically guided handpiece 12 in afluid or saline environment within the joint. It can be underarthroscopic visualization by the surgeon, or the apparatus can includea viewing device. The invention accurately controls the application ofheat within a specific thermal range, and delivers thermal energy tocollagen soft tissue of the joint, thereby contracting and restrictingthe soft tissue elasticity and improving joint stability. When appliedto the shoulder, there is capsular shrinkage of the gleno-humoral jointcapsule of the shoulder and a consequent contracture of the volume, theinterior circumference, of the shoulder capsule to correct for recurrentinstability symptoms. The degree of capsular shrinkage is determined bythe operating surgeon, based on severity of preoperative symptoms andcondition of the capsule at the time of arthroscopic inspection. Themaximum amount of collagen contraction achieved is approximatelytwo-thirds of its original structure.

In FIG. 20, a loose capsule is illustrated. The apparatus for controlcontraction of tissue of the present invention is applied to a jointcapsule (FIG. 21). Electrode distal end 18 is painted across the surfaceof the collagen soft tissue. FIGS. 23 and 24 illustrate the applicationof the invention to a herniated disc.

While embodiments and applications of this invention have been shown anddescribed, it will be apparent to those skilled in the art that manymore modifications than mentioned above are possible without departingfrom the invention concepts herein. The invention, therefore, is not tobe restricted except in the spirit of the appended claims.

What is claimed is:
 1. A method for repairing ligaments, joint capsules and connective tissue through the controlled contraction of collagen fibers, the method comprising:providing an apparatus including a handle and an electrode having an electrode proximal end attached to the handle and an electrode distal end, the distal end including an energy delivering distal electrode portion having a surface with radiused edges for delivering substantially uniform energy across the surface of the energy delivering distal electrode portion; positioning the energy delivering distal electrode portion adjacent to an area of collagen fibers to be contracted; delivering substantially uniform energy across the surface of the energy delivering distal electrode portion to the area of collagen fibers; and contracting the collagen fibers through the application of energy to the collagen fibers.
 2. The method of claim 1 further including the step ofdelivering an electrolytic solution to the area of collagen fibers, the electrolytic solution serving to provide a substantially uniform distribution of energy from the electrode to the collagen fibers.
 3. The method of claim 1 further including the step ofdelivering an electrolytic gel to the area of collagen fibers, the electrolytic solution serving to provide a substantially uniform distribution of energy from the electrode to the collagen fibers.
 4. The method of claim 1 further including the step of controlling the temperature of the collagen fibers to minimize the dissociation and breakdown of the collagen fibers and to minimize the ablation of tissue neighboring the collagen fibers.
 5. The method of claim 1 further comprising the step of moving the energy delivering distal electrode portion relative to the area of collagen fibers being contracted during the delivery of energy to the area of collagen fibers in order to control the temperature of the collagen fibers so that dissociation and breakdown of collagen fibers is minimized and ablation of tissue neighboring the collagen fibers is minimized.
 6. The method of claim 1, wherein the step of contracting the collagen fibers causes the collagen fibers to be contracted to about two-thirds of its initial size.
 7. The method of claim 1, where the energy penetrates the collagen fibers to a depth of at least about 1 mm.
 8. The method of claim 7, where the energy penetrates the collagen fibers to a depth of between about 1 and 3 mm.
 9. The method of claim 9 further including the step ofdelivering an electrolytic solution to the area of collagen fibers, the electrolytic solution serving to provide a substantially uniform distribution of energy from the electrode to the collagen fibers, the electrolytic solution also serving to control the temperature of the collagen fibers.
 10. The method of claim 9 further including the step ofdelivering an electrolytic gel to the area of collagen fibers, the electrolytic solution serving to provide a substantially uniform distribution of energy from the electrode to the collagen fibers, the electrolytic gel also serving to control the temperature of the collagen fibers.
 11. The method of claim 1, wherein the energy delivering distal electrode portion delivers RF energy to the area of collagen fibers.
 12. The method of claim 11, wherein the RF energy penetrates the collagen fibers to thermally contract the collagen fibers substantially without ablating neighboring tissue.
 13. The method of claim 1, wherein the energy is applied only to the surface of the tissue.
 14. The method of claim 1, wherein the step of positioning the energy delivering distal electrode portion includes positioning the energy delivering distal electrode portion adjacent to an area of collagen fibers in a joint capsule.
 15. The method of claim 14 wherein the joint capsule is a gleno-humoral joint capsule of a shoulder. 